Accuretic

Main information

  • Trade name:
  • Accuretic 12.5mg/20mg Film coated tablet
  • Dosage:
  • 12.5mg/20mg
  • Pharmaceutical form:
  • Film coated tablet
  • Units in package:
  • Aluminium foil, blister, sample pack, 10 tablets
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Cambrex Profarmaco Milano Srl

Documents

Localization

  • Available in:
  • Accuretic 12.5mg/20mg Film coated tablet
    New Zealand
  • Language:
  • English

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 9644
  • Authorization date:
  • 25-02-2000
  • Last update:
  • 27-09-2017

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

ACCURETIC

®

Quinapril hydrochloride and Hydrochlorothiazide

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Accuretic.

It does not contain all the available

information.

It does not take the place of talking to

your doctor or pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking Accuretic

against the benefits it is expected to

have for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Accuretic is

used for

Accuretic is a combination of a

medicine called angiotensin

converting enzyme (ACE) inhibitor

and a diuretic "water tablet".

Accuretic is used to lower high blood

pressure (hypertension). Everyone

has blood pressure. This pressure

helps get your blood all around your

body. Your blood pressure may be

different at different times of the day,

depending on how busy or worried

you are. You have hypertension

(high blood pressure) when your

blood pressure stays higher than is

needed, even when you are calm and

relaxed.

There are usually no symptoms of

hypertension. The only way of

knowing that you have hypertension

is to have your blood pressure

checked on a regular basis. If high

blood pressure is not treated it can

lead to serious health problems,

including stroke, heart disease and

kidney failure.

How Accuretic works

Accuretic works by widening your

blood vessels, which reduces

pressure in the vessels, making it

easier for your heart to pump blood

around your body.

Accuretic also works by making your

kidneys pass more water and salt and

retain more potassium. This helps

reduce high blood pressure.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

Your doctor may have prescribed it

for another reason.

This medicine is not addictive.

This medicine is available only with

a doctor's prescription.

Use in Children

The safety and effectiveness of

Accuretic in children have not been

established.

Before you take

Accuretic

When you must not take it

Do not take Accuretic if you have

an allergy to:

any medicine containing quinapril

hydrochloride or

hydrochlorothiazide

any of the ingredients listed at the

end of this leaflet

any sulfonamide or sulfur

medicines.

One of the active ingredients of

Accuretic, hydrochlorothiazide, is

a sulfur-containing medicine (a

sulfonamide). Therefore, if you

are allergic to sulfur medicines,

such as some antibiotics, you are

likely to be allergic to Accuretic.

Check with your doctor or

pharmacist if you are not sure

whether you are allergic to sulfur

medicines.

Symptoms of an allergic reaction

to Accuretic may include skin

rash, itchiness, shortness of

breath, swelling of the face, lips

or tongue, muscle pain or

tenderness or joint pain.

Do not take Accuretic if:

you have taken any other 'ACE

inhibitor' medicine before, which

caused your face, lips, tongue,

throat, hands or feet to swell up,

or made it hard for you to breathe

If you have had an allergic

reaction to an ACE inhibitor

before, you may be allergic to

Accuretic

you or your family have a history

of swelling of the face, lips,

tongue, throat, hands or feet for

no apparent reason

you have kidney problems or a

condition called 'renal artery

stenosis'

you have regular dialysis for

blood filtration.

You may experience an allergic

reaction.

ACCURETIC

Do not take Accuretic if you are

currently taking a blood pressure

lowering medicine containing

aliskiren or with medicines known

as angiotensin receptor blockers

(ARB) or other ACE inhibitors

and you have the following

conditions:

diabetes

kidney problems

high levels of potassium in your

blood

congestive heart failure.

You may experience severe side

effects.

Do not take Accuretic if you are

currently taking a neutral

endopeptidase inhibitor, used to

treat high blood pressure or heart

failure.

Taking Accuretic with a neutral

endopeptidase inhibitor (e.g.,

sacubitril/ valsartan combination)

increases your risk of angioedma,

rapid swelling of your face, lips,

mouth, tongue or throat and may

result in difficulty in swallowing or

breathing.

Do not take Accuretic if you are

pregnant or breastfeeding.

Accuretic may enter your womb or it

may pass into the breast milk and

there is the possibility that your baby

may be affected.

Do not take Accuretic after the

expiry date printed on the pack or

if the packaging is torn or shows

signs of tampering.

If you are not sure whether you

should start taking this medicine,

talk to your doctor.

Before you start to take it

Tell your doctor if you have

allergies to:

any other medicines

any other substances, such as

foods, preservatives or dyes.

Tell your doctor if you have or

have had any medical conditions,

especially the following:

kidney problems, or are having

dialysis

liver problems

heart problems

low blood pressure, which you

may notice as dizziness or light-

headedness

diabetes

high levels of potassium in your

blood

gout

high cholesterol

Systemic Lupus Erythematosus

(SLE), scleroderma or other

autoimmune diseases.

You must also tell your doctor if

you:

are following a very low salt diet

are about to receive

desensitisation therapy for an

allergy

are about to undergo dialysis or

lipoprotein apheresis

are about to have surgery or a

general anaesthetic

plan to become pregnant or

breastfeed.

If you have not told your doctor

about any of the above, tell

him/her before you start taking

Accuretic.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including:

all prescription medicines

all medicines, vitamins, herbal

supplements or natural therapies

you buy without a prescription

from a pharmacy, supermarket,

naturopath or health food shop.

Some medicines may be affected by

Accuretic or may affect how well it

works. You may need different

amounts of your medicines, or you

may need to take different medicines.

Your doctor will advise you.

Tell your doctor or pharmacist if

you are taking any of the

following:

other medicines used to treat high

blood pressure

other medicines that work in a

similar fashion to ACE inhibitors,

such as Angiotensin Receptor

Blockers (these are used to treat

high blood pressure and/or heart

failure)

digoxin, a medicine used to treat

heart failure

neutral endopeptidase inhibitor

(e.g., sacubitril/ valsartan

combination), a medicine used to

treat high blood pressure or heart

failure.

other diuretics, also known as

fluid or water tablets

non-steroidal anti-inflammatory

drugs (NSAIDs) or Cox 2

inhibiting medicines used to

relieve pain, swelling and other

symptoms of inflammation,

including arthritis

allopurinol, a medicine used to

treat gout

potassium supplements or

potassium-containing salt

substitutes

lithium, a medicine used to treat

mood swings and some types of

depression

tetracycline antibiotics

trimethoprim or

trimethoprim/sulfamethoxazole,

medicines used to treat bacterial

infections

any other antibiotics and

medicines to treat infections

steroid medicines such as

cortisone, prednisone

insulin and tablets used to treat

diabetes

barbiturates, used to treat

epilepsy, such as phenobarbitone

strong pain killers such as

codeine, morphine,

dextropropoxyphene

ACCURETIC

cholestyramine and colestipol,

used to treat high cholesterol

medicines used to relax muscles

before and during surgery

medicines used in emergency

situations such as adrenaline.

Tell your doctor if you are taking

any of the following blood pressure

lowering medicines:

angiotensin II receptor blocker

(ARB)

aliskiren.

For some patients, Accuretic should

not be taken in combination with

these medicines.

Your doctor may check your kidney

function, blood pressure and the

amount of electrolytes (e.g.

potassium) in your blood at regular

intervals.

Tell your doctor if you are taking

any of the following medicines:

mTOR inhibitors (e.g.

temsirolimus), used in the

treatment of kidney cancer

DPP-IV inhibitors (e.g.

vildagliptin), used in the

treatment of diabetes.

Taking Accuretic in combination

with these medicines may increase

your risk of having an allergic

reaction.

If you are not sure if you are taking

any of the medicines mentioned in

this leaflet, check with your doctor or

pharmacist.

Your doctor and pharmacist may

have more information on medicines

to be careful with or avoid while

taking Accuretic.

How to take Accuretic

Follow all directions given to you

by your doctor or pharmacist

carefully.

They may differ from the

information contained in this leaflet.

If you do not understand the

instructions on the box, ask your

doctor or pharmacist for help.

How much to take

Your doctor or pharmacist will tell

you how many Accuretic tablets you

need to take each day. This may

depend on your condition and

whether or not you are taking any

other medicines.

For most patients, the usual starting

dose is one Accuretic 10 mg/12.5 mg

tablet a day. The dose may need to

be increased to one Accuretic

20 mg/12.5 mg tablet a day, then two

Accuretic 10 mg/12.5 mg tablets a

day if necessary. Most patients take

between 10 mg/12.5 mg to

20 mg/12.5 mg daily. Each dose

may be taken once a day.

How to take it

Swallow the tablets whole with a

full glass of water.

Do not chew the tablets.

When to take it

Take Accuretic at about the same

time each day, with or without

food.

Taking it at the same time each day

will have the best effect. It will also

help you remember when to take the

tablets.

It does not matter whether you take it

with or without food.

How long to take it

Continue taking your medicine for

as long as your doctor tells you.

Accuretic helps control your

condition, but does not cure it. It is

important to keep taking your

medicine every day even if you feel

well.

If you forget to take it

If it is almost time for your next

dose, skip the dose you missed and

take your next dose when you are

meant to.

Otherwise, take it as soon as you

remember and then go back to

taking your medicine as you would

normally.

Do not take a double dose to make

up for the dose that you missed.

This may increase the chance of you

getting an unwanted side effect.

If you are not sure what to do, ask

your doctor or pharmacist.

If you have trouble remembering

to take your medicine, ask your

pharmacist for some hints.

If you take too much

(overdose)

Immediately telephone your doctor

or the Australian Poisons

Information Centre (telephone 13

11 26) or the New Zealand

National Poisons Information

Centre (telephone 0800 POISON

or 0800 764 766), or go to Accident

and Emergency at the nearest

hospital, if you think that you or

anyone else may have taken too

much Accuretic.

Do this even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention.

If you take too much Accuretic, you

may feel light-headed, dizzy or you

may faint. You may also become

thirsty, confused, have a change in

the amount of urine passed or have a

fast heartbeat.

While you are taking

Accuretic

Things you must do

If you are about to be started on

any new medicine, tell your doctor,

dentist or pharmacist that you are

taking Accuretic.

Make sure you drink enough water

during exercise and hot weather

when you are taking Accuretic,

especially if you sweat a lot.

ACCURETIC

If you do not drink enough water

while taking Accuretic, you may feel

faint, light-headed or sick. This is

because your blood pressure is

dropping suddenly. If you continue

to feel unwell, tell your doctor.

Tell your doctor if you have excess

vomiting and/or diarrhoea while

taking Accuretic, or you have any

of the following symptoms:

dry mouth, thirst

weakness, tiredness, drowsiness

muscle pains or cramps

fast heart beat

passing less urine than normal.

You may be dehydrated because you

are losing too much water.

Tell your doctor immediately if

you feel light-headed or dizzy after

taking your first dose of Accuretic,

or when your dose is increased.

If you are going to have surgery

that needs a general anaesthetic,

tell your doctor or dentist that you

are taking Accuretic.

Your blood pressure may drop

suddenly.

If you become pregnant while

taking Accuretic, tell your doctor

immediately.

If you are about to have any blood

tests, tell your doctor that you are

taking Accuretic.

Accuretic may interfere with the

results of some tests.

Have your blood pressure checked

when your doctor says, to make

sure Accuretic is working.

Go to your doctor regularly for a

check-up.

Your doctor may occasionally do a

blood test to check your potassium

levels and see how your kidneys are

working.

Things you must not do

Do not give your medicine to

anyone else, even if they have the

same condition as you.

Do not take Accuretic to treat any

other complaints unless your

doctor or pharmacist tells you to.

Do not stop taking Accuretic, or

change the dosage, without

checking with your doctor.

Things to be careful of

If you feel light-headed, dizzy or

faint when getting out of bed or

standing up, get up slowly.

Standing up slowly, especially when

you get up from bed or chairs, will

help your body get used to the

change in position and blood

pressure. If this problem continues

or gets worse, talk to your doctor.

Drinking alcohol may make these

symptoms worse. If it does, reduce

your consumption of alcohol.

Be careful driving or operating

machinery until you know how

Accuretic affects you.

As with other medicines in this class,

Accuretic may cause dizziness, light-

headedness or tiredness in some

people. Make sure you know how

you react to Accuretic before you

drive a car, operate machinery, or do

anything else that could be dangerous

if you are dizzy or light-headed. If

this occurs do not drive. If you drink

alcohol, dizziness or light-

headedness may be worse.

Things that would be helpful

for your blood pressure

Some self-help measures suggested

below may help your condition.

Talk to your doctor or pharmacist

about these measures and for more

information.

Alcohol

Your doctor may advise you to limit

your alcohol intake.

Weight

Your doctor may suggest losing

some weight to help lower your

blood pressure and help lessen the

amount of work your heart has to do.

Some people may need a dietician's

help to lose weight.

Diet

Eat a healthy diet which includes

plenty of fresh vegetables, fruit,

bread (preferably wholegrain),

cereals and fish. Also eat less sugar

and fat (especially saturated fat)

which includes sausages, fatty meats,

full cream dairy products, biscuits,

cakes, pastries, chocolates, chips and

coconut. Monounsaturated and

polyunsaturated fats from olive oil,

canola oil, avocado and nuts are

beneficial in small quantities.

Salt

Your doctor may advise you to watch

the amount of salt in your diet. To

reduce your salt intake you should

avoid using salt in cooking or at the

table and avoid cooked or processed

foods containing high sodium (salt)

levels.

Exercise

Regular exercise, maintained over

the long term, helps to reduce blood

pressure and helps get the heart fitter.

Regular exercise also improves your

blood cholesterol levels, helps reduce

your weight and stress levels, and

improves your sleep, mood and

ability to concentrate. However, it is

important not to overdo it. Before

starting any exercise, ask your doctor

about the best kind of programme for

you.

Smoking

Your doctor may advise you to stop

smoking or at least cut down. Ask

your doctor or pharmacist for further

information and advice.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

Accuretic.

All medicines can have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medical treatment if you get some of

the side effects.

ACCURETIC

It can be difficult to tell whether side

effects are the result of taking

Accuretic, effects of your condition

or side effects of other medicines you

may be taking. For this reason it is

important to tell your doctor of any

change in your condition.

If you are over 65 years of age you

may have an increased chance of

getting side effects.

Do not be alarmed by the list of

side effects.

You may not experience any of them.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor if…

Ask your doctor or pharmacist for

advice if you notice any of the

following and they worry you:

feeling light-headed, dizzy or

faint

dry cough

headache

feeling sick (nausea) or vomiting

stomach pain

diarrhoea

constipation

unusual tiredness or weakness,

fatigue

sleepiness or drowsiness

difficulty in getting or

maintaining an erection

(impotence)

runny or blocked nose, or

sneezing

taste disturbances or loss of taste

confusion or nervousness

restlessness

back pain

indigestion

sore throat and discomfort when

swallowing

rash.

These side effects are usually mild.

All side effects should be reported to

a health professional.

Tell your doctor as soon as

possible if…

Tell your doctor as soon as possible

if you notice any of the following:

eye pain, vision problems

blurred vision or yellow vision

itchy or raised skin rash, hives or

nettle rash

muscle cramps

symptoms of sunburn (such as

redness, itching, swelling,

blistering) which may occur more

quickly than normal

signs of anaemia such as

tiredness, being short of breath

and looking pale

tingling or numbness in the

hands, feet or ankles

severe upper stomach pain, often

with nausea and vomiting

signs of worrying or frequent

infections such as fever, severe

chills, sore throat or mouth ulcers

aching, tender or weak joints or

muscles not caused by exercise

passing little or no urine

swelling of the hands, feet or

ankles

bleeding or bruising more easily

than normal

yellowing of the skin and/or eyes.

The above list includes serious side

effects that may require medical

attention. Serious side effects are

rare.

Go to hospital if…

Tell your doctor immediately or go

to Accident and Emergency at

your nearest hospital, if you notice

any of the following:

fainting within a few hours of

taking a dose

fast or irregular heart beat

shortness of breath or tightness in

the chest

sudden or general weakness, or

weakness in the arms or legs

sudden onset of stomach pains or

cramps with or without nausea or

vomiting

pink or red itchy spots on the skin

which may blister and progress to

form raised, red, pale-centred

marks

severe flaking or peeling of the

skin

severe blisters and bleeding in the

lips, eyes, mouth, nose and

genitals

severe skin reaction which starts

with painful red areas, then large

blisters and ends with peeling of

layers of skin. This may be

accompanied by fever and chills,

aching muscles and generally

feeling unwell

chest pain

loss of vision; may be temporary

or more gradual.

These are very serious side effects.

You may need urgent medical

attention or hospitalisation. These

side effects are very rare.

Stop taking Accuretic and tell your

doctor immediately or go to

Accident and Emergency at your

nearest hospital if you notice the

following:

Swelling of the face, lips, mouth,

tongue or throat which may cause

difficulty in swallowing or

breathing.

Tell your doctor or pharmacist if

you notice anything that is making

you feel unwell.

Other side effects not listed above

may also occur in some people.

After taking Accuretic

Storage

Keep your tablets in the box until

it is time to take them.

If you take the tablets out of the box

they may not keep well.

ACCURETIC

Keep your tablets in a cool dry

place where the temperature stays

below 25 °C.

Do not store Accuretic or any other

medicine in the bathroom or near a

sink.

Do not leave it on a windowsill or

in the car on hot days.

Heat and dampness can destroy some

medicines.

Keep it where children cannot

reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

If your doctor or pharmacist tells

you to stop taking this medicine or

the expiry date has passed, ask

your pharmacist what to do with

any medicine that is left over.

Product description

What it looks like

Accuretic tablets come in two

strengths and each has a different

appearance:

Accuretic 10 mg/12.5 mg - Pink,

oval, biconvex, film-coated

tablets, scored on both sides

Accuretic 20 mg/12.5 mg - Pink,

triangular, biconvex, film-coated

tablets, scored on one side

A box of Accuretic contains 30

tablets.

Ingredients

Active ingredients:

Accuretic 10 mg/12.5 mg - 10 mg

quinapril hydrochloride and 12.5

mg hydrochlorothiazide per tablet

Accuretic 20 mg/12.5 mg - 20 mg

quinapril hydrochloride and 12.5

mg hydrochlorothiazide per tablet

Other ingredients:

crospovidone

lactose

magnesium carbonate

magnesium stearate

povidone

candelilla wax

Opadry Pink OY-S-6937.

Accuretic does not contain sucrose,

gluten, tartrazine or any other azo

dyes.

Supplier

Accuretic is supplied in Australia by:

Pfizer Australia Pty Ltd

ABN 50 008 422 348

38-42 Wharf Road

West Ryde NSW 2114

Australia.

Toll Free Number: 1800 675 229.

Accuretic is supplied in New Zealand

Pfizer New Zealand Limited

PO Box 3998

Auckland

New Zealand.

Toll Free Number: 0800 736 363.

Australian Registration

Numbers

Accuretic 10 mg/12.5 mg - AUST R

81930.

Accuretic 20 mg/12.5 mg - AUST R

81931.

This leaflet was prepared in March

2017.

© Pfizer Australia Pty Ltd 2017.

Registered Trade Mark.

ACCURETIC

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Europe - EFSA - European Food Safety Authority EFSA Journal

9-1-2019

Review of the existing maximum residue levels for sedaxane according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for sedaxane according to Article 12 of Regulation (EC) No 396/2005

Published on: Tue, 08 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance sedaxane. To assess the occurrence of sedaxane residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, the MRLs established by the Codex Alimentarius Commission as well as the...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-1-2019

Review of the existing maximum residue levels for triazoxide according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for triazoxide according to Article 12 of Regulation (EC) No 396/2005

Published on: Tue, 08 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance triazoxide. To assess the occurrence of triazoxide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member States. Bas...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-1-2019

Review of the existing maximum residue levels for chromafenozide according to Article 12 Regulation (EC) No 396/2005

Review of the existing maximum residue levels for chromafenozide according to Article 12 Regulation (EC) No 396/2005

Published on: Tue, 08 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance chromafenozide. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for chromafenozide within the EU. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue limits) for this active subst...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-12-2018

Terrific Care, LLC. / Medex Supply Dist, Inc. issues Nationwide Recall of CoaguChek Test Strips

Terrific Care, LLC. / Medex Supply Dist, Inc. issues Nationwide Recall of CoaguChek Test Strips

On 12/19/2018, Terrific Care, LLC. / Medex Supply Dist, Inc. initiated a nationwide recall of Roche CoaguChek test strips distributed directly to U.S. consumers by Terrific Care, LLC. / Medex Supply Dist, Inc. The products have been found to inaccurately report high INR test results.

FDA - U.S. Food and Drug Administration

19-12-2018

Wegmans Issues Voluntary Recall of Fresh Cauliflower Rice, Veggie/Cauliflower Rice Blend and Stir-Fry Mix with Cauliflower

Wegmans Issues Voluntary Recall of Fresh Cauliflower Rice, Veggie/Cauliflower Rice Blend and Stir-Fry Mix with Cauliflower

Rochester, NY – Wegmans Food Markets, Inc. has issued a voluntary recall of fresh Cauliflower Rice, Veggie Cauliflower Rice Blend and Stir-Fry Mix with Cauliflower, sold in the produce department between 12/7/18 and 12/18/18, because it may be contaminated with Escherichia coli O157:H7 bacteria (E. Coli O157:H7). E. coli O157:H7 causes a diarrheal illness often with bloody stools. Although most healthy adults can recover completely within a week, some people can develop a form of kidney failure called He...

FDA - U.S. Food and Drug Administration

18-12-2018

Apo-Prednisone 5 mg Tablet (2018-12-18)

Apo-Prednisone 5 mg Tablet (2018-12-18)

Health Canada

18-12-2018

Review of the existing maximum residue levels for pencycuron according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for pencycuron according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 17 Dec 2018 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance pencycuron. To assess the occurrence of pencycuron residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

17-12-2018

Vijf jaar NIX brengt normverandering roken en drinken op gang

Vijf jaar NIX brengt normverandering roken en drinken op gang

Op 1 januari is het precies vijf jaar geleden dat de leeftijdsgrens voor roken en drinken werd verhoogd naar 18 jaar. In deze periode is er veel veranderd, blijkt uit een recente peiling in opdracht van het ministerie van VWS. Zo vindt ongeveer driekwart van de ouders en tieners het ‘normaal’ dat je pas mag roken en drinken vanaf 18 jaar. 78,2% van de ouders vindt dit tegenover 75,4% van de jongeren. De afgelopen jaren is het gebruik van alcohol onder tieners teruggelopen. Sinds 2011 gaat het in de total...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

17-12-2018

Teva Canada Product Recall (2018-12-17)

Teva Canada Product Recall (2018-12-17)

Health Canada

14-12-2018


Management Board meeting: 12-13 December 2018, European Medicines Agency, London, UK, from 12/12/2018 to 13/12/2018

Management Board meeting: 12-13 December 2018, European Medicines Agency, London, UK, from 12/12/2018 to 13/12/2018

Management Board meeting: 12-13 December 2018, European Medicines Agency, London, UK, from 12/12/2018 to 13/12/2018

Europe - EMA - European Medicines Agency

14-12-2018


European Medicines Agency stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH), European Medicines Agency, London, UK, from 03/12/2018 to 03/12/2018

European Medicines Agency stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH), European Medicines Agency, London, UK, from 03/12/2018 to 03/12/2018

European Medicines Agency stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH), European Medicines Agency, London, UK, from 03/12/2018 to 03/12/2018

Europe - EMA - European Medicines Agency

13-12-2018

Evaluation of the safety and efficacy of the organic acids lactic and acetic acids to reduce microbiological surface contamination on pork carcasses and pork cuts

Evaluation of the safety and efficacy of the organic acids lactic and acetic acids to reduce microbiological surface contamination on pork carcasses and pork cuts

Published on: Wed, 12 Dec 2018 Studies evaluating the safety and efficacy of lactic and acetic acids to reduce microbiological surface contamination on pork carcasses pre‐chill and pork meat cuts post‐chill were assessed. Lactic acid treatments consisted of 2–5% solutions at temperatures of up to 80°C applied to carcasses by spraying or up to 55°C applied on cuts by spraying or dipping. Acetic acid treatments consisted of 2–4% solutions at temperatures of up to 40°C applied on carcasses by spraying or o...

Europe - EFSA - European Food Safety Authority Publications

13-12-2018

Pest categorisation of Septoria malagutii

Pest categorisation of Septoria malagutii

Published on: Wed, 12 Dec 2018 The Panel on Plant Health performed a pest categorisation of Septoria malagutii, the causal agent of annular leaf spot of potato, for the EU. The pest is a well‐defined fungal species and reliable methods exist for its detection and identification. S. malagutii is present in Bolivia, Ecuador, Peru and Venezuela. The pest is not known to occur in the EU and is listed as Septoria lycopersici var. malagutii in Annex IAI of Directive 2000/29/EC, meaning its introduction into t...

Europe - EFSA - European Food Safety Authority Publications

13-12-2018

The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2017

The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2017

Published on: Wed, 12 Dec 2018 This report of the European Food Safety Authority and the European Centre for Disease Prevention and Control presents the results of zoonoses monitoring activities carried out in 2017 in 37 European countries (28 Member States (MS) and nine non-MS). Campylobacteriosis was the commonest reported zoonosis and its EU trend for confirmed human cases increasing since 2008 stabilised during 2013–2017. The decreasing EU trend for confirmed human salmonellosis cases since 2008 end...

Europe - EFSA - European Food Safety Authority Publications

12-12-2018

Enforcement Report for the Week of December 12, 2018

Enforcement Report for the Week of December 12, 2018

Recently Updated Records for the Week of December 12, 2018 Last Modified Date: Wednesday, December 12, 2018

FDA - U.S. Food and Drug Administration

8-12-2018

Annual assessment of Echinococcus multilocularis surveillance reports submitted in 2018 in the context of Commission Regulation (EU) No 1152/2011

Annual assessment of Echinococcus multilocularis surveillance reports submitted in 2018 in the context of Commission Regulation (EU) No 1152/2011

Published on: Fri, 07 Dec 2018 This report is part of the `Echinococcus multilocularis surveillance’ scientific reports which are presented annually by EFSA to the European Commission and are intended to assess the sampling strategy, data collection and detection methods used by Finland, Ireland, Malta, the United Kingdom (UK) and Norway in their respective surveillance programmes. The surveillance programmes of these five countries were evaluated by checking the information submitted by each of them an...

Europe - EFSA - European Food Safety Authority Publications

7-12-2018

Fine Land Corp Issues Allergy Alert on Undeclared Milk Allergens in “Meiqili Durian Candy”

Fine Land Corp Issues Allergy Alert on Undeclared Milk Allergens in “Meiqili Durian Candy”

Fine Land Corp is recalling it’s 12 ounce (340 g) Meiqili Durian Candy in plastic bag with clear window because it contains undeclared milk allergens. Consumers who are allergic to milk allergens may run the risk of serious or life – threatening allergic reactions if they consume this product.

FDA - U.S. Food and Drug Administration

7-12-2018

Magnesium citrate malate as a source of magnesium added for nutritional purposes to food supplements

Magnesium citrate malate as a source of magnesium added for nutritional purposes to food supplements

Published on: Thu, 06 Dec 2018 The present scientific opinion deals with the assessment of the bioavailability of magnesium, from the proposed nutrient source, magnesium citrate malate (MgCM), when added for nutritional purposes to food supplements. MgCM is a mixed salt consisting of magnesium cations and citrate and malate anions, and with a magnesium content of 12–15%. MgCM is proposed to be used in food supplements that are intended to provide up to 300–540 mg/day magnesium. The data provided demonst...

Europe - EFSA - European Food Safety Authority Publications

6-12-2018

Country Flavor Inc Issues Alert on Undeclared Sulfites In "Best Taste Brand Dried Bamboo Shoot"

Country Flavor Inc Issues Alert on Undeclared Sulfites In "Best Taste Brand Dried Bamboo Shoot"

Country Favor Inc. of Maspeth, New York is recalling its 12 ounce packages of "Best Taste Brand DRIED BAMBOO SHOOT" food treats because they contained undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.

FDA - U.S. Food and Drug Administration

16-1-2019

EU/3/12/1062 (EUSA Pharma (Netherlands) B.V.)

EU/3/12/1062 (EUSA Pharma (Netherlands) B.V.)

EU/3/12/1062 (Active substance: Chimeric monoclonal antibody against GD2) - Transfer of orphan designation - Commission Decision (2019)238 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003198

Europe -DG Health and Food Safety

11-1-2019

Consultation: Good Clinical Practice Inspections Program

Consultation: Good Clinical Practice Inspections Program

The TGA is seeking comments from interested parties on a pilot Good Clinical Practice (GCP) Inspections Program of 12 months duration that will inform a routine GCP Inspections Program. Closing date: 22 February 2019

Therapeutic Goods Administration - Australia

20-12-2018

TGA presentations: CAPSIG Seminar, 12 September 2018

TGA presentations: CAPSIG Seminar, 12 September 2018

Overview of regulatory requirements introduced as part of PIC/s PE009-13 Guide to GMP and a summary of the new PI041-1 Data Integrity

Therapeutic Goods Administration - Australia

19-12-2018

On 12/12/18 GE Healthcare Recalled CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA has identified this as a Class I Recall, the most serious type recall. Read more about the recall:  https://go.usa.gov/

On 12/12/18 GE Healthcare Recalled CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA has identified this as a Class I Recall, the most serious type recall. Read more about the recall: https://go.usa.gov/

On 12/12/18 GE Healthcare Recalled CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA has identified this as a Class I Recall, the most serious type recall. Read more about the recall: https://go.usa.gov/xE383  #MedicalDevice #FDA pic.twitter.com/S2EbMdmwpe

FDA - U.S. Food and Drug Administration

19-12-2018

EU/3/12/1087 (Richardson Associates Regulatory Affairs Ltd)

EU/3/12/1087 (Richardson Associates Regulatory Affairs Ltd)

EU/3/12/1087 (Active substance: Recombinant modified human growth hormone) - Transfer of orphan designation - Commission Decision (2018)9014 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002652

Europe -DG Health and Food Safety

18-12-2018


Human medicines European public assessment report (EPAR): Dengvaxia, dengue tetravalent vaccine (live, attenuated), Dengue, Date of authorisation: 12/12/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Dengvaxia, dengue tetravalent vaccine (live, attenuated), Dengue, Date of authorisation: 12/12/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Dengvaxia, dengue tetravalent vaccine (live, attenuated), Dengue, Date of authorisation: 12/12/2018, Status: Authorised

Europe - EMA - European Medicines Agency

18-12-2018

EU/3/12/963 (Helsinn Birex Pharmaceuticals Ltd)

EU/3/12/963 (Helsinn Birex Pharmaceuticals Ltd)

EU/3/12/963 (Active substance: Chlormethine) - Transfer of orphan designation - Commission Decision (2018)9016 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002753

Europe -DG Health and Food Safety

18-12-2018

Consultation: Review of Therapeutic Goods Order 54 - Standards for Disinfectants; and associated guidance

Consultation: Review of Therapeutic Goods Order 54 - Standards for Disinfectants; and associated guidance

TGA is seeking comments on the expansion and amendment of TGO 54. Closing date: 12 February 2019

Therapeutic Goods Administration - Australia

17-12-2018


Orphan designation: Nanoliposomal irinotecan, Treatment of pancreatic cancer, 09/12/2011, Positive

Orphan designation: Nanoliposomal irinotecan, Treatment of pancreatic cancer, 09/12/2011, Positive

Orphan designation: Nanoliposomal irinotecan, Treatment of pancreatic cancer, 09/12/2011, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Adcetris,brentuximab vedotin,  13/12/2018,  Positive

Summary of opinion: Adcetris,brentuximab vedotin, 13/12/2018, Positive

Summary of opinion: Adcetris,brentuximab vedotin, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Trecondi,treosulfan,  13/12/2018,  Positive

Summary of opinion: Trecondi,treosulfan, 13/12/2018, Positive

Summary of opinion: Trecondi,treosulfan, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Besremi,ropeginterferon alfa-2b,  13/12/2018,  Positive

Summary of opinion: Besremi,ropeginterferon alfa-2b, 13/12/2018, Positive

Summary of opinion: Besremi,ropeginterferon alfa-2b, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Lusutrombopag Shionogi,lusutrombopag,  13/12/2018,  Positive

Summary of opinion: Lusutrombopag Shionogi,lusutrombopag, 13/12/2018, Positive

Summary of opinion: Lusutrombopag Shionogi,lusutrombopag, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Rapiscan,regadenoson,  13/12/2018,  Positive

Summary of opinion: Rapiscan,regadenoson, 13/12/2018, Positive

Summary of opinion: Rapiscan,regadenoson, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Miglustat Dipharma,miglustat,  13/12/2018,  Positive

Summary of opinion: Miglustat Dipharma,miglustat, 13/12/2018, Positive

Summary of opinion: Miglustat Dipharma,miglustat, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Tobramycin PARI,tobramycin,  13/12/2018,  Positive

Summary of opinion: Tobramycin PARI,tobramycin, 13/12/2018, Positive

Summary of opinion: Tobramycin PARI,tobramycin, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Withdrawn application: Fyzoclad, adalimumab, Date of withdrawal: 05/12/2018, Initial authorisation

Withdrawn application: Fyzoclad, adalimumab, Date of withdrawal: 05/12/2018, Initial authorisation

Withdrawn application: Fyzoclad, adalimumab, Date of withdrawal: 05/12/2018, Initial authorisation

Europe - EMA - European Medicines Agency

14-12-2018


Withdrawn application: Canakinumab Novartis, canakinumab, Date of withdrawal: 04/12/2018, Initial authorisation

Withdrawn application: Canakinumab Novartis, canakinumab, Date of withdrawal: 04/12/2018, Initial authorisation

Withdrawn application: Canakinumab Novartis, canakinumab, Date of withdrawal: 04/12/2018, Initial authorisation

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Trimbow,beclometasone / formoterol / glycopyrronium bromide,  13/12/2018,  Positive

Summary of opinion: Trimbow,beclometasone / formoterol / glycopyrronium bromide, 13/12/2018, Positive

Summary of opinion: Trimbow,beclometasone / formoterol / glycopyrronium bromide, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Simponi,golimumab,  13/12/2018,  Positive

Summary of opinion: Simponi,golimumab, 13/12/2018, Positive

Summary of opinion: Simponi,golimumab, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Sprycel,dasatinib,  13/12/2018,  Positive

Summary of opinion: Sprycel,dasatinib, 13/12/2018, Positive

Summary of opinion: Sprycel,dasatinib, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Rizmoic,naldemedine,  13/12/2018,  Positive

Summary of opinion: Rizmoic,naldemedine, 13/12/2018, Positive

Summary of opinion: Rizmoic,naldemedine, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Rubraca,rucaparib,  13/12/2018,  Positive

Summary of opinion: Rubraca,rucaparib, 13/12/2018, Positive

Summary of opinion: Rubraca,rucaparib, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Zirabev,bevacizumab,  13/12/2018,  Positive

Summary of opinion: Zirabev,bevacizumab, 13/12/2018, Positive

Summary of opinion: Zirabev,bevacizumab, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

12-12-2018

Oncaspar (Les Laboratoires Servier)

Oncaspar (Les Laboratoires Servier)

Oncaspar (Active substance: pegaspargase) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8757 of Wed, 12 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3789/T/21

Europe -DG Health and Food Safety

12-12-2018

Daklinza (Bristol-Myers Squibb Pharma EEIG)

Daklinza (Bristol-Myers Squibb Pharma EEIG)

Daklinza (Active substance: daclatasvir) - Centralised - Yearly update - Commission Decision (2018)8758 of Wed, 12 Dec 2018

Europe -DG Health and Food Safety

12-12-2018

EVOTAZ (Bristol-Myers Squibb Pharma EEIG)

EVOTAZ (Bristol-Myers Squibb Pharma EEIG)

EVOTAZ (Active substance: atazanavir / cobicistat) - Centralised - Yearly update - Commission Decision (2018)8679 of Wed, 12 Dec 2018

Europe -DG Health and Food Safety

12-12-2018

Elocta (Swedish Orphan Biovitrum AB (publ))

Elocta (Swedish Orphan Biovitrum AB (publ))

Elocta (Active substance: efmoroctocog alfa) - Centralised - Variation - Commission Decision (2018)8678 of Wed, 12 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3964/X/21

Europe -DG Health and Food Safety

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Four independent DNA plasmid vectors encoding HBV antigens and human interleukin-12

Scientific recommendation on classification of advanced therapy medicinal products: Four independent DNA plasmid vectors encoding HBV antigens and human interleukin-12

Scientific recommendation on classification of advanced therapy medicinal products: Four independent DNA plasmid vectors encoding HBV antigens and human interleukin-12

Europe - EMA - European Medicines Agency

7-12-2018


Summary of opinion: Evant,eimeria acervulina, strain 003 / eimeria maxima, strain 013 / eimeria mitis, live / eimeria praecox, live / eimeria tenella, strain 004,  06/12/2018,  Positive

Summary of opinion: Evant,eimeria acervulina, strain 003 / eimeria maxima, strain 013 / eimeria mitis, live / eimeria praecox, live / eimeria tenella, strain 004, 06/12/2018, Positive

Summary of opinion: Evant,eimeria acervulina, strain 003 / eimeria maxima, strain 013 / eimeria mitis, live / eimeria praecox, live / eimeria tenella, strain 004, 06/12/2018, Positive

Europe - EMA - European Medicines Agency

7-12-2018


Summary of opinion: Kriptazen,halofuginone,  06/12/2018,  Positive

Summary of opinion: Kriptazen,halofuginone, 06/12/2018, Positive

Summary of opinion: Kriptazen,halofuginone, 06/12/2018, Positive

Europe - EMA - European Medicines Agency

7-12-2018


Summary of opinion: Zulvac BTV Ovis,bluetongue vaccine (inactivated),  06/12/2018,  Positive

Summary of opinion: Zulvac BTV Ovis,bluetongue vaccine (inactivated), 06/12/2018, Positive

Summary of opinion: Zulvac BTV Ovis,bluetongue vaccine (inactivated), 06/12/2018, Positive

Europe - EMA - European Medicines Agency

7-12-2018


Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Europe - EMA - European Medicines Agency

7-12-2018


Orphan designation: tiratricol, Treatment of Allan-Herndon-Dudley syndrome, 12/10/2017, Positive

Orphan designation: tiratricol, Treatment of Allan-Herndon-Dudley syndrome, 12/10/2017, Positive

Orphan designation: tiratricol, Treatment of Allan-Herndon-Dudley syndrome, 12/10/2017, Positive

Europe - EMA - European Medicines Agency

5-12-2018


Cilazapril, cilazapril / hydrochlorothiazide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation -  PSUSA-00000749-201802

Cilazapril, cilazapril / hydrochlorothiazide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA-00000749-201802

Cilazapril, cilazapril / hydrochlorothiazide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA-00000749-201802

Europe - EMA - European Medicines Agency

5-12-2018


Cilazapril, cilazapril / hydrochlorothiazide: List of nationally authorised medicinal products -  PSUSA-00000749-201802

Cilazapril, cilazapril / hydrochlorothiazide: List of nationally authorised medicinal products - PSUSA-00000749-201802

Cilazapril, cilazapril / hydrochlorothiazide: List of nationally authorised medicinal products - PSUSA-00000749-201802

Europe - EMA - European Medicines Agency